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NCT03860259 · ClinicalTrials.gov registry record · NA
Auriculotherapy for Surgical Pain
A NA study, sponsored by Jacques E. Chelly.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03860259 is a NA study that has completed, run by Jacques E. Chelly. The registered enrollment target is 50 participants.
The verdict
NCT03860259, a NA study, has completed, sponsored by Jacques E. Chelly.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and elect
Interventions
- DEVICE Auriculotherapy cryopuncture device without nitrogen gas
- DEVICE Auriculotherapy cryopuncture device with nitrogen gas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-01-24 |
| Est. Completion | 2021-09-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03860259
The ClinicalTrials.gov registry entry for NCT03860259 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jacques E. Chelly, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Auriculotherapy cryopuncture device without nitrogen gas is the first listed.
NCT03860259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03860259 about?
NCT03860259 is a clinical study titled "Auriculotherapy for Surgical Pain". The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depre...
What is the current status of trial NCT03860259?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2020-01-24. Estimated completion is 2021-09-29.
What interventions are being tested in trial NCT03860259?
The interventions under investigation include: Auriculotherapy cryopuncture device without nitrogen gas (DEVICE), Auriculotherapy cryopuncture device with nitrogen gas (DEVICE).
Who is sponsoring clinical trial NCT03860259?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
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